Secondary Prevention of Schizophrenia. A randomized controlled trial

精神分裂症是一种慢性疾病，对个人、家庭和社会造成毁灭性后果。近年来，新的临床发现和假说表明，精神分裂症的二级预防（SPS）是可能的。虽然非典型精神抑制剂（AN）和认知行为治疗（CBT）已被用于二级预防工作，由于方法的局限性，预防效果仍然不确定，CBT和AN的差异疗效的人在有前驱症状的精神病（PAR）的风险是未知的。因此，PREVENT以高度的方法学严谨性解决了以下主要研究问题：（1）临床管理和阿立哌唑联合治疗（CM+ARI）是否比CM和安慰剂联合治疗（CM+PL）对有精神病前驱症状（PAR）风险的患者更有效？(2)认知行为疗法（CBT）是否比CM+PL更有效？(3)CBT在PAR中的效果不比CM+ARI差吗？在7个早期检测和干预中心，将在30个月期间招募380名PAR，进行一项为期12个月的平行组随机对照试验，采用3种研究条件[CM+ ARI、CM+PL（双盲）、CBT（盲法评级）]。关于SPS的主要目的“预防/延迟向精神病转变”的积极PREVENT结果将证明SPS作为精神卫生保健的标准实践是合理的。此外，他们将建议CBT与AN相当有效。因此，PAR将受益于预防策略的选择。因此，接受，容忍和遵守SPS的努力，在PAR，在他们的家庭和一般人群可能会改善和精神卫生系统的负担，残疾和精神分裂症的经济后果的影响可能会加强。

Schizophrenia is a chronic disease with devastating consequences for individuals, families and society. In recent years, new clinical findings and hypotheses suggested that secondary prevention of schizophrenia (SPS) may be possible. Although atypical neuroleptics (AN) and cognitive-behavioral therapy (CBT) have been used in secondary prevention efforts, due to methodological limitations the preventive effects remains uncertain and the differential efficacy of CBT and AN for persons at risk of being prodromally symptomatic for psychosis (PAR) is unknown. Therefore PREVENT addresses the following principal research questions with high methodological rigor: (1) Are clinical management and aripiprazole combined (CM+ARI) more effective in persons at risk of being prodromally symptomatic for psychosis (PAR) than CM and placebo combined (CM+PL)? (2) Is cognitive-behavioral therapy (CBT) more effective in PAR than CM+PL? (3) Is CBT not less effective in PAR than CM+ARI? At 7 early detection and intervention centers 380 PAR will be recruited over a 30-months period in a 12-months parallel group randomized controlled trial with three study conditions [CM+ ARI, CM+PL (double-blind), CBT (blinded ratings)]. Positive PREVENT results with regard to the primary aim of SPS “prevention/delay of transition to psychosis” will justify SPS as a standard practice in mental health care. Moreover, they will suggest that CBT is comparable effective to AN. Thus PAR will benefit from a choice of prevention strategies. Thereby acceptance, tolerance and compliance with SPS efforts in PAR, in their families and in the general population is likely to improve and the impact of the mental health system on burden, disability and economical consequences of schizophrenia might be strengthened.